Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06678893
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2024-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ear Acupuncture for Pain and Anxiety Management in Early Labor
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Study Overview
Official Title:
Pilor Trial of Auricular Acupuncture for Latent Labor-Related Pain and Anxiety
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study evaluating the feasibility and acceptability of ear acupuncture for the management of pain and anxiety in early labor.
Detailed Description:
This double blinded randomized controlled pilot study will take place in the Emergency Department of Women and Infants Hospital (WIH) in Providence Rhode Island. This study seeks to assess feasibility and acceptability utilizing the 5 Needle Protocol of Auricular Acupuncture (5NP, AA) during early labor for management of pain and anxiety. At the time of emergency department evaluation at Women and Infants Hospital for a chief complaint of painful contractions, the investigators will enroll 40 pregnant people as a feasibility sample investigating the impact of auricular acupuncture (AA) on patient-reported pain and anxiety in early labor. Participants will be randomized to either AA using the 5 Needle protocol versus placebo acupuncture. While the data on the efficacy of auricular acupuncture for pain and anxiety is mounting, evidence for utility in treating labor pain is limited. This proposal will be one of the first to randomize pregnant people presenting with concern for pain or anxiety related to labor contractions to this potential treatment.
The investigator's long-term goal is to find an effective treatment option for a common labor complaint while improving satisfaction with pain management in the Emergency Department. Given this is a pilot study, the primary objective is to determine feasibility of implementing a randomized control trial evaluating the effect of auricular acupuncture as an initial treatment for improving perceived pain and anxiety symptoms related to contractions. The central hypothesis is that this is indeed feasible and acceptable in the Emergency Department setting of Women and Infants Hospital in Rhode Island. The secondary objective is to assess the trend that auricular acupuncture has on pain and anxiety scores, as well as on heart rate and blood pressure. Though the sample size is aimed to assess feasibility and will not be sufficiently powered for an efficacy analysis, if trends suggest that auricular acupuncture decreases pain and/or anxiety sores, further investigation with a larger randomized control trial will be warranted.
Eligible participants for this trial include Spanish or English speaking patients 18 years or older who are in early labor with a singleton pregnancy greater than or equal to 37+0 weeks gestation, and willing to be randomized to receive auricular acupuncture versus placebo. Early labor will be defined as less than 6 centimeters dilated and experiencing at least 2 contractions in ten minutes, per patient report and/or tocometry. Exclusion criteria include patients less than 18 years of age, non-Spanish or English-speaking patients, multi-gestation, preterm labor, greater than or equal to 6 cm dilated, less than 2 contractions in 10 minutes, morphine or nitrous oxide administration within the last two hours, congenital anomalies, open wounds or skin disorders of the ear, previous adverse reactions to acupuncture and/or allergies or contraindications to adhesives.
The investigator's long-term goal is to find an effective treatment option for a common labor complaint while improving satisfaction with pain management in the Emergency Department. Given this is a pilot study, the primary objective is to determine feasibility of implementing a randomized control trial evaluating the effect of auricular acupuncture as an initial treatment for improving perceived pain and anxiety symptoms related to contractions. The central hypothesis is that this is indeed feasible and acceptable in the Emergency Department setting of Women and Infants Hospital in Rhode Island. The secondary objective is to assess the trend that auricular acupuncture has on pain and anxiety scores, as well as on heart rate and blood pressure. Though the sample size is aimed to assess feasibility and will not be sufficiently powered for an efficacy analysis, if trends suggest that auricular acupuncture decreases pain and/or anxiety sores, further investigation with a larger randomized control trial will be warranted.
Eligible participants for this trial include Spanish or English speaking patients 18 years or older who are in early labor with a singleton pregnancy greater than or equal to 37+0 weeks gestation, and willing to be randomized to receive auricular acupuncture versus placebo. Early labor will be defined as less than 6 centimeters dilated and experiencing at least 2 contractions in ten minutes, per patient report and/or tocometry. Exclusion criteria include patients less than 18 years of age, non-Spanish or English-speaking patients, multi-gestation, preterm labor, greater than or equal to 6 cm dilated, less than 2 contractions in 10 minutes, morphine or nitrous oxide administration within the last two hours, congenital anomalies, open wounds or skin disorders of the ear, previous adverse reactions to acupuncture and/or allergies or contraindications to adhesives.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: